Local Hospital Says No Incidents With Robotic Surgery

FDA Taking New Look at da Vinci

May 5, 2013

STEUBENVILLE - A local hospital says it has had no problems using the da Vinci robot during surgeries - the same machine now under scrutiny by the Food and Drug Administration.

The da Vinci is the biggest thing in operating rooms these days. It is a million-dollar, multi-armed robot used in nearly 400,000 surgeries nationwide last year - triple the number just four years earlier. But now the high-tech helper is under scrutiny over reports of problems, including several deaths that may be linked with it and the high cost of using the robotic system.

There also have been a few disturbing, freak incidents: a robotic hand that wouldn't let go of tissue grasped during surgery and a robotic arm hitting a patient in the face as she lay on the operating table.

Article Photos

AP File PhotoDr. Pier Giulianotti, chief of minimally invasive and robotic surgery at the University of Illinois Hospital and Health Sciences System in Chicago, sits at the control panel of the da Vinci robot system.

Is it time to curb the robot enthusiasm? Some doctors say yes, concerned that the ''wow'' factor and heavy marketing have boosted use. They argue that there is not enough research showing that robotic surgery is at least as good or better than conventional surgeries. Many U.S. hospitals aggressively promote robotic surgery in patient brochures and online.

Their aim is partly to attract business that helps pay for the costly robot.

Locally, the only hospital using the da Vinci is Trinity Health Systems of Steubenville. For about the past three months, two of its physicians, Dr. Patrick Macedonia and Dr. Sam Licata, have performed more than 40 operations using the $2 million robot. Trinity spokesman Keith Murdock said his hospital has not had any complications or problems related to use of the da Vinci robot.

"We believe our surgeons have been properly trained and certified to use that system," Murdock said, noting the certification comes from the company that makes the machine.

If an issue did arise, Murdock said use of the robot would stop immediately and be investigated by the hospital.

"We're not anticipating any problems," he said, noting patients have a choice in whether to use robot-assisted surgery. "We haven't had any incidents at all."

Trinity uses the robot for general surgeries such as appendectomies and gynecological surgeries such as hysterectomies.

For example, during a traditional surgery a laparoscopic appendectomy involves use of three incisions, while using the robot requires only one incision, Murdock said.

"With the single incision site, there's less bleeding and less scarring," he said.

The da Vinci is used for operations that include removing prostates, gallbladders and wombs, repairing heart valves, shrinking stomachs and transplanting organs. Its use has increased worldwide, but the system is most popular in the United States.

"We are at the tip of the iceberg. What we thought was impossible 10 years ago is now commonplace," Dr. Michael Stifelman, robotic surgery chief at New York University's Langone Medical Center, said.

For surgeons, who control the robot while sitting at a computer screen rather than standing over the patient, these operations can be less tiring. Plus robot hands don't shake. Advocates say patients sometimes have less bleeding and often are sent home sooner than with conventional laparoscopic surgeries and operations involving large incisions.

But the FDA is looking into a spike in reported problems during robotic surgeries. Earlier this year, the FDA began a survey of surgeons using the robotic system. The agency conducts such surveys of devices routinely, but FDA spokeswoman Synim Rivers said the reason for it now "is the increase in number of reports received" about da Vinci. Reports filed since early last year include at least five deaths.

Whether there truly are more problems recently is uncertain. Rivers said she couldn't quantify the increase and that it may simply reflect more awareness among doctors and hospitals about the need to report problems. Doctors aren't required to report such things; device makers and hospitals are. It could also reflect wider use. Last year there were 367,000 robot surgeries versus 114,000 in 2008, according to da Vinci's maker, Intuitive Surgical Inc. of Sunnyvale, Calif.

Da Vinci is the company's only product, and it's the only robotic system cleared for soft-tissue surgery by the FDA. There are other robotic devices approved for neurosurgery and orthopedics, among other things.

A search for the company's name in an FDA database of reported problems related to medical devices brings up 500 reports since Jan. 1, 2012. Many of those came from Intuitive Surgical. The reports include incidents that happened several years ago and some are duplicates.

There's also no proof any of the problems were caused by the robot, and many didn't injure patients. Reports filed this year include:

- A woman who died during a 2012 hysterectomy when the surgeon-controlled robot accidentally nicked a blood vessel.

- A Chicago man who died in 2007 after spleen surgery.

- A New York man whose colon was allegedly perforated during prostate surgery. Da Vinci's maker filed that report after seeing a newspaper article about it and said the doctor's office declined to provide additional information.

- A robotic arm that wouldn't let go of tissue grasped during colorectal surgery on Jan. 14. "We had to do a total system shutdown to get the grasper to open its jaws," said the report filed by the hospital. The report said the patient was not injured.

- A robotic arm hit a patient in the face during a hysterectomy. The company filed that report, and said it is unknown if the patient was injured but that the surgeon decided to switch to an open, more invasive operation instead.

Intuitive Surgical filed all but one of those reports.

Complications can occur with any type of surgery, and so far it's unclear if they are more common in robotic operations, but that's part of what the FDA is trying to find out. Intuitive Surgical disputes there's been a true increase in problems and says the rise reflects a change it made last year in the way it reports problems. The da Vinci system "has an excellent safety record with over 1.5 million surgeries performed globally, and total adverse event rates have remained low and in line with historical trends," company spokeswoman Angela Wonson noted.

But an upcoming research paper suggests that problems linked with robotic surgery are under reported. They include cases with "catastrophic complications," Dr. Martin Makary, a Johns Hopkins surgeon who co-authored the paper, said.

"The rapid adoption of robotic surgery ... has been done by and large without the proper evaluation," Makary said.

The da Vinci system, on the market since 2000, includes a three- or four-armed robot that surgeons operate with hand controls at a computer system located several feet away from the patient.

They see inside the patient's body through a tiny video camera attached to one of the long robot arms.